Identity
- Trade Name
- Allen EUDAMEDFDA UDI
- Generic Name
- Urological fluid funnel FDA UDI
- Device Name
- LP-Non-Sterile URO Catcher EUDAMEDFluid Collector, Bariatric FDA UDI
- Model / Reference
- P056397967 EUDAMED102006 FDA UDI
- Description
- Fluid Collector, Bariatric FDA UDI
Identifiers
- Catalog Number
- P056397967 FDA UDI
- Primary DI / UDI-DI
- 00615521020675 EUDAMEDFDA UDI
- Basic UDI-DI
- 0615521GMN1020067Q EUDAMED
- FDA Product Code
- NNW FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Urological fluid funnel FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Allen by Hill-Rom, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0615521GMN1020067Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hill-Rom, Inc.
- EUDAMED SRN
- US-MF-000007306
- Authorised Representative
- Hill-Rom S.A.S. FR-AR-000003177
Sources (2)
- EUDAMED fc83e17d-7880-4c27-866c-9d599f436749 61 fields · synced Jul 28, 2026
- FDA UDI 44958597-efb1-4e94-8874-ba3fa4771223 35 fields · synced May 30, 2026